ASCRS doesn't mince words when it comes to the new Standards documents

Thu, 2004-10-07 13:55

Hot off the wires, a press release from The American Society of Cataract and Refractive Surgery entitled, "ASCRS Sharply Criticizes Conflict of Interest Guidance for Updated Continuing Medical Education Accreditation Standards."

Fairfax, VA -- The American Society of Cataract and Refractive Surgery (ASCRS) today sharply criticized implementation guidelines for the Accreditation Council for Continuing Medical Education s (ACCME) updated Standards for Commercial Support. If allowed to stand, the guidance, entitled, "Identifying and Resolving Conflicts of Interest in Continuing Medical Education, Implementing the 2004 Updated ACCME Standards for Commercial Support," (to be referred to as the guidance document) will undermine continuing medical education programs, suppress truthful speech, slow innovation and development of new products and therapies, and hurt patient welfare.

"The basic assumption that the guidance document seems to make is that anyone with any type of a relationship with a commercial interest is immediately corrupted by that relationship," said Warren Hill, MD, chair of the ASCRS CME Advisory Committee. "That assumption is wrong," he said.

The approach taken in the guidance document undermines medical education because it moves from identifying and disclosing conflicts of interest to censorship, Hill added. The document contains so-called "corrective" actions that ominously prescribe censorship and suppression of speech as "mechanisms to identify and resolve conflicts of interest." Those mechanisms include: "Alter control over content," "Change the focus of the CME activity," "Change the content of the person's assignment," "Limit the content to a report without recommendations," and "Limit the sources for recommendations" (emphasis added).

The guidance fails to recognize the realities of continuing medical education for small subspecialties. "What about those of us who work closely with industry in an area with only a few experts? Are none of us to give presentations for medical education? Or do we only talk about topics with which we have no experience?" Hill asked.

"ASCRS was founded by pioneers involved with the creation of phacoemulsification and intraocular lens (IOL) implantation. Each of these individuals worked closely with industry to create a cataract treatment procedure that has become the standard of care. Had the new conflict of interest restraints been in place at that time, cataract surgery and visual rehabilitation would not be what it is today. Indeed, the same can be said for laser-based vision correction and the emerging field of refractive intraocular lenses," said Priscilla P. Arnold, MD, ASCRS president.

Moreover, the guidance document fails to acknowledge the realities of bringing innovations from the theoretical stage to clinical application. "One of the unique features of ophthalmology is that most of the true innovators in this field have worked closely with industry, which is how their innovations have been brought forward. Without this close relationship, progress in many areas of ophthalmology would be much slower," Hill said, adding, "to the extent that innovation is slowed or stifled, patient welfare is undermined."

"The proper way to deal with conflict of interest is to disclose financial relationships so that all who have access to information can evaluate it in light of that disclosure. Medical science, as any area of inquiry, flourishes in an environment of robust debate and the free flow of ideas and information," Hill said.

"We believe the guidance document prescribes censorship that is a clear violation of First Amendment rights because of their content-based restrictions on truthful speech. ASCRS also believes there is no justification for suppressing speech unless there is good reason to believe that the speech is false. As a CME provider, ASCRS adheres to the belief that doctors can better evaluate what they are told by a speaker if the speaker discloses all potential sources of bias. We believe that there is no justification for suppressing truthful speech altogether based solely on a fear of potential sources of bias," Hill said.

"The guidance document makes the Standards Draconian; it is injurious to scientific inquiry. It should be replaced with implementation guidance that advances patient welfare by supporting vigorous free speech, robust debate, identification of conflicts of interest, and full disclosure of financial relationships. Fears of conflicts of interest do not justify censorship, and truthful speech cannot be suppressed solely on a fear of potential sources of bias," Hill concluded.

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